Canon Medical System, USA, INC. Recall 87419
Description: System INFX-8000C
Canon Medical System, USA, INC. Recall 87419 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-1175-2021 |
| Event ID | 87419 |
| Event Description | System INFX-8000C |
| Product Type | Devices |
| Distribution | Nationwide |
| Quantity | 272 in total |
| Recall Reason | The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles. |
| Device Classification | 20210317 |
| Device Code Info | Model: CAS-880A, CAS-830B |
| Center Classification Date | 20210309 |
| Recall Initiation Date | 20210205 |
| Recalling Firm | Canon Medical System, USA, INC. |
| Initial Notification | Letter |
| Similar To |